1. Related Field
Testing system for assessing the level of a biochemical marker, comprising a disposable device with a sample inlet and a at least one visible detection compartment, arranged with composition including a chemical means for direct detection of said biochemical marker.
2. Description of Related Art
Biochemical analysis of biochemical markers from blood and other body fluids are probably the most commonly performed diagnostic test besides clinical examination of a patients. Biochemical analysis could be performed at home (e.g. pregnancy test, glucose monitoration in diabetic patients), in hospital or the physician's office on a point of care device (e.g. hemoglobin, blood gases, lactate, electrolytes) or at the department of clinical chemistry where broad panels of routine biochemical markers or highly specialized single biochemical markers are analysed on huge automatized equipment.
In many aspects the department of clinical chemistry is superior when it comes to moderately quick and cost effective analysis. However in some situations lack of time, lack of appropriate amount of body fluid needed for analysis or the localisation (e.g. at home or when medical care is given at a significant distance from the department of clinical chemistry) excludes the department of clinical chemistry as a possible way to perform the needed analysis. In these situations some kind of point of care (POC) device is the most effective, or sole, solution to insure safe medical care for the individual patient. POC is the generic word for medical care that could be performed where the patient is located. When it comes to POC in-vitro diagnostic devices for analysis of one or several biochemical markers in a specific body fluid from a patient a broad spectrum of technical solutions are commercially available. The simplest form of a POC in-vitro diagnostic device, in terms of how the result is presented to the user, could be exemplified by the pregnancy test where the presence of the hormone human chorionic gonadotropin (HCG) in urine will be shown as a colour, a line or a “plus” sign. Much more advanced are the different analysing equipments, the size of huge microwave ovens, where many of the analyses performed at the department of clinical chemistry could be analysed point-of-care.
When it comes to POC technology the medical care giver has to do a trade-off between simple-to-use qualitative devices like the urine dipstick and the expensive, hefty but sophisticated lab-on-a-bench equipment giving full quantitative results on most of the biochemical analysis needed in modern medical care.
Numerous systems have been suggested to minimise one or more of the problems mentioned above. For instance, U.S. 2006/0222567 suggests the use of a mobile device, having a specifically designed accessory and a specific software to provide the ability of analysing a test in situ, i.e. to more or less instantly may display a test result. However, this solution presents some disadvantages, e.g. that it requires specific accessories, which most likely will be very costly. Furthermore, it may also be a disadvantage that it requires a mobile device having a relatively large processor capacity to run the program and the need of actually installing the program on each one of said mobile units. In its preferred form U.S. 2006/0222567 uses a digital picture, taken by the mobile unit, that is processed, i.e. regarding colour (change/intensity) to determine the test result. This may imply some requirements/restrictions on the equipment and the software that may not always be accomplished. Furthermore it may require the use of undesirably costly substances to obtain a sufficiently distinct colour change for the testing.